The present invention relates generally to vascular infusion systems and components, including catheter assemblies and devices used with catheter assemblies. In particular, the present invention relates to safety devices configured to prevent rupture of infusion components due to excessive fluid pressure within a vascular infusion system.
Vascular access devices are used for communicating fluid with the anatomy of a patient. For some diagnostic procedures, a vascular access device is used for infusing a contrast media into the vascular system of a patient. The contrast material is generally radiopaque thereby enabling diagnosis of various parameters of the patient's vascular system via CT or MRI scan imaging.
A trend in diagnostic imaging procedures is to enhance visualization by increasing the viscosity and the injection rate of the contrast media. These rapid infusion methods produce enhanced bolus density of the injected contrast media resulting in improved image quality. However, these methods also generate increased pressure within vascular access devices resulting in the increased likelihood of infusion component rupture. Additionally, line patency is often compromised by patient or catheter position, as well as flow rate induced kinking also leading to increased pressure within the various vascular access devices.
As a result of these challenges, the Food and Drug Administration has received numerous adverse event reports in which vascular access devices have ruptured when used with power injectors to administer contrast media as part of CT studies. The ruptured devices have included peripheral catheters, central venous catheters, implanted ports, extension tubing, and intravenous administration sets. Many of these ruptures have resulted in device fragmentation, embolism or migration requiring surgical intervention, extravasations of contrast media, loss of venous access requiring device replacement, physical injury to the patient, and contamination of room and personnel with blood and contrast media.
Accordingly, the problem of excessive pressure buildup during rapid infusion procedures remains to be solved. Thus, the present disclosure presents systems and methods to prevent undesirable rupture of infusion components, as is commonly experienced during rapid infusion procedures.